title: Antiviral efficacy of entecavir in nucleos(t)ide-naïve patients of Black/African descent with chronic hepatitis B.
abstract: This single-arm, open-label, descriptive study assessed the efficacy and safety of entecavir (ETV) in nucleos(t)ide-naïve Black/African American patients with chronic hepatitis B (CHB), a patient population underrepresented in ETV registration trials. Forty patients with HBeAg(+) or HBeAg(-) compensated CHB of self-described Black/African American race received ETV 0.5 mg daily for 52 weeks; 37 patients completed 52 weeks of treatment. At Week 48, 29/40 (72.5%, noncompleter = failure) patients achieved the primary endpoint of HBV DNA <50 IU/mL. Rates for HBeAg loss (11/22; 50%) and HBeAg seroconversion (9/22; 41%) were high, possibly due to the high HBV genotype A prevalence (70%). No patient experienced virological breakthrough. Samples for resistance testing were available in 6/8 patients with HBV DNA >50 IU/mL at Week 48 or last on-treatment visit. No ETV resistance was detected. The safety profile of ETV was consistent with that observed in ETV registration trials. This study shows that in Black/African American patients with CHB, ETV was well tolerated and demonstrated comparable antiviral efficacy to that observed in White and Asian patients in ETV Phase III studies.
authors.affiliation: Center for Liver Diseases, University of Miami, Miami, FL, USA.
authors.forename: L
authors.initials: L
authors.lastname: Jeffers
authors.forename: C J
authors.initials: CJ
authors.lastname: Van Rensburg
authors.forename: A
authors.initials: A
authors.lastname: Banks
authors.forename: M
authors.initials: M
authors.lastname: Schechter
authors.forename: S J
authors.initials: SJ
authors.lastname: Schmidt
authors.forename: W
authors.initials: W
authors.lastname: Hu
authors.forename: C
authors.initials: C
authors.lastname: Llamoso
authors.forename: R
authors.initials: R
authors.lastname: Parana
mesh_terms: D000328:Adult; D001741:Black or African American; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D004279:DNA, Viral / Q000097:blood; D005260:Female; D006147:Guanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000187:drug effects / Q000302:isolation & purification; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008826:Microbial Sensitivity Tests; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; C413685:entecavir; D006147:Guanine
keywords: antiviral therapy; hepatitis B e antigen; hepatitis B virus DNA; nucleos(t)ide analogue